Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
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ClinicalTrials.gov Identifier: NCT01109069 |
Recruitment Status :
Completed
First Posted : April 22, 2010
Results First Posted : May 7, 2020
Last Update Posted : May 27, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
B-cell Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Diffuse Well-differentiated Lymphocytic Lymphoma B Cell Lymphoma Follicular Lymphoma Mantle Cell Lymphoma Non-Hodgkin's Lymphoma Waldenstrom Macroglobulinemia Burkitt Lymphoma B-Cell Diffuse Lymphoma | Drug: PCI-32765 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 199 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | April 26, 2019 |
Actual Study Completion Date : | April 26, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: PCI-32765 |
Drug: PCI-32765
Dose based on parent protocol |
- Number of Subjects With Adverse Events [ Time Frame: 30 days after last dose of study drug, continue up to 6 months ]Subjects were to receive ibrutinib once daily at the dose level the subject was receiving in the parent study until disease progression or unacceptable toxicity. The study included Screening, Treatment (from the first dose until study drug discontinuation), and Follow-up Phases.
- Progressive Disease (PD) [ Time Frame: 30 days after last dose of study drug, continue up to 6 months ]A progressive disease confirmed by a CT scan.
- Death Event [ Time Frame: 30 days after last dose of study drug ]All death events are due to AE, progressive disease, and other reasons.
- Documented Responses [ Time Frame: 30 days after last dose of study drug, continue up to 6 months ]Investigator-assessed responses were summarized descriptively for subjects with CLL/SLL and listed for subjects with other NHLs based on the efficacy population.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women with recurrent surface immunoglobulin positive B cell non-Hodgkin's lymphoma (NHL) according to WHO classification (including, but not limited to, CLL/SLL, Waldenström's macroglobulinemia [WM], mantle cell lymphoma [MCL], and diffuse large B cell lymphoma [DLBCL) who have met requirements for roll over from their parent protocol and want to continue study drug.
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug and agree to use dual methods of contraception during the study and for 1 month following the last dose with study drug. Post menopausal females (>45 years old and without menses for >1 year) and surgically sterilized females are exempt from this criterion.
- Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential.
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
Exclusion Criteria:
- A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
- Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection.
- Lactating or pregnant

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109069
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 | |
Stanford, California, United States, 94305 | |
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Massachusetts | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
New Hyde Park, New York, United States, 11042 | |
New York, New York, United States, 10065 | |
Rochester, New York, United States, 14642-0001 | |
United States, Ohio | |
Columbus, Ohio, United States, 43210 | |
United States, Oregon | |
Springfield, Oregon, United States, 97477 | |
United States, Tennessee | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Houston, Texas, United States, 77030 | |
Tyler, Texas, United States, 75702 | |
United States, Vermont | |
Fletcher Allen Health Care and University of Vermont | |
Burlington, Vermont, United States, 05405 | |
United States, Washington | |
Vancouver, Washington, United States, 98684 | |
Yakima Valley Memorial Hospital/North Star Lodge | |
Yakima, Washington, United States, 98902 |
Study Director: | James Dean, MD | Medical Monitor |
Documents provided by Pharmacyclics LLC.:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pharmacyclics LLC. |
ClinicalTrials.gov Identifier: | NCT01109069 |
Other Study ID Numbers: |
PCYC-1103-CA PCI-32765 ( Other Identifier: Pharmacyclics ) |
First Posted: | April 22, 2010 Key Record Dates |
Results First Posted: | May 7, 2020 |
Last Update Posted: | May 27, 2020 |
Last Verified: | March 2020 |
PCI-32765 Lymphoma, B-Cell Leukemia, Lymphoid Leukemia, B-Cell Bruton's Tyrosine Kinase |
Burkitt Lymphoma Lymphoma Leukemia Lymphoma, Non-Hodgkin Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, B-Cell Lymphoma, Mantle-Cell Waldenstrom Macroglobulinemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Leukemia, B-Cell Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |